ZEBinix® Retention Rate in Epilepsy in Elderly Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The incidence of provoked and unprovoked seizures is known to increase with advancing age. Eslicarbazepine acetate (ESL) is one of the third generation of antiepileptic drugs (AEDs) that have been developed in the last ten years with a favorable safety profile. ESL is approved in Europe and the USA as adjunctive or monotherapy in adults with partial-onset seizures. Nevertheless, retrospective data in monotherapy condition in the elderly epileptic population are sparse. The aim of the ZEBRE study is to evaluate the efficacy and the safety of ESL in elderly epileptic patients (\> 65 years). The completion of this study will provide crucial information on the most appropriate ESL treatment for elderly patients suffering from partial seizures.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

NCT03082222

Focal Epilepsy

COMPLETED

Clinical Trial for Zebinix (Eslicarbazepine Acetate) in Healthy Korean and Caucasian Adult

NCT04095182

Partial-onset Seizures With or Without Secondary Generalisation

COMPLETED PHASE1

Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients

NCT01422720

Epilepsy

COMPLETED PHASE3

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures

NCT00988429

Partial Epilepsy

COMPLETED PHASE3

A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures

NCT03116828

Epilepsy With Partial On-set Seizures

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The ZEBRE (ZEBinix® Retention rate in epilepsy in Elderly patients) study is a prospective, multicenter, descriptive study. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy Aging Disorder Aging Epilepsy; Seizure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Epileptic elderly patients

Elderly patients with partial-onset seizures

Zebinix

Intervention Type DRUG

ESL will be initiated by the investigator in patients as a first line monotherapy or adjunctive therapy. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics. Then, data on the efficacy of ESL will be collected.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zebinix

ESL will be initiated by the investigator in patients as a first line monotherapy or adjunctive therapy. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics. Then, data on the efficacy of ESL will be collected.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Eslicarbazepine acetate (ESL)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 65 years
2. Ability of patient/legal representative to understand the study and to give his/her non-opposition (at the investigator's discretion)
3. Epilepsy with refractory partial-onset seizures with or without secondary generalization confirmed or with primary generalized tonic-clonic (PGTC) seizures
4. At least one seizure in the last three months
5. Treatment for partial-onset seizures with ESL as a first line monotherapy or with an adjunctive therapy

Exclusion Criteria

1. History of ESL treatment
2. History of status epilepticus, seizures occurring in cluster, pseudo-seizures
3. History of severe hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2 times ULN, gamma-glutamyltranspeptidase (GGT) \> 5 times ULN)
4. History of severe renal impairment (clearance CLCR \<30ml/min)
5. History of hypersensitivity to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine)
6. History of severe hyponatremia (\< 120 mmol/L)
7. Second or third degree atrioventricular block
8. More than one other antiepileptic drug

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No